NCT02134158

Brief Summary

The aim of this trial is to quantify the improvement of locomotion and equilibrium induced par tDCS in anode polarity position in post stroke hemiplegic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 10, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2016

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 13, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

December 18, 2013

Last Update Submit

March 12, 2019

Conditions

Gait Disorders

Keywords

tDCS, gait disorders, equilibrium, hemiplegic, stroke

Outcome Measures

Primary Outcomes (1)

  • Quantify of variability of the center-of-mass movement

    Variability of the center-of-mass will be quantified during walking analysis and equilibrium assessment, for experimental and placebo visits (before, during and after stimulation) (V2 and V3) as well as in inclusion visit (V1).

    30 minutes

Secondary Outcomes (3)

  • Symmetry index calculating

    30 Minutes

  • Continuous relative phase

    30 Minutes

  • Functional data

    30 minutes

Study Arms (2)

sham and then anodal

EXPERIMENTAL

visit 2 sham stimulation (120 seconds) and visit 3 anodal stimulation (30 minutes)

Device: anodal tDCS and sham tDCS stimulations

anodal and then sham

EXPERIMENTAL

visit 2 anodal stimulation (30 minutes) and visit 3 sham stimulation (120 seconds)

Device: anodal tDCS and sham tDCS stimulations

Interventions

anodal tDCS and sham tDCS stimulationsDEVICE

Two conditions will be tested in randomized order: 2 arms in the first one anodal tDCS and then sham tDCS. In the other arm sham tDCS and then anodal tDCS. All the investigations will associate with clinical, functional and 3D motion analysis assessments.

anodal and then shamsham and then anodal

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults
  • Unilateral stroke
  • More than 6 months after stroke
  • Ability to walk during 10 minutes without stopping
  • Informed consent signed

You may not qualify if:

  • Patient with pacemaker
  • Claustrophobia (unable to perform a magnetic resonance imaging analysis)
  • Patient with severe aphasia or severe cognitive disorder interfering the follow-up of the trial
  • Neuro-orthopedic surgery history in the last 6 months on the studied paretic lower limb
  • Epilepsy history in the last year
  • Lack of medical insurance
  • Adult patient under the care of a guardian
  • Patient with progressive concomitant disease
  • Patient with deep brain stimulation treatment (implantation of medical device)
  • Patient with implantation of Intracranial metallic clip
  • Patient with implantation of Intracranial stent
  • Patient with implantation of ventriculoperitoneal derivation
  • Patient with implantation of intracerebral or ocular prosthetic materials
  • Patient with ferro-magnetic foreign object
  • Patient with cochlear implant
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raymond Poincaré Hospital

Garches, Hauts-de-Seine, 92380, France

Location

Related Publications (1)

  • Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials. 2017 Oct 23;18(1):492. doi: 10.1186/s13063-017-2219-6.

    PMID: 29061169DERIVED

MeSH Terms

Conditions

Mobility LimitationStroke

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nicolas ROCHE, MD, PhD

    Laboratory of Movement Analysis, Raymond Poincaré Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

May 9, 2014

Study Start

July 10, 2014

Primary Completion

August 5, 2016

Study Completion

September 1, 2018

Last Updated

March 13, 2019

Record last verified: 2019-02

Locations

FR(1)